Lung Cancer Clinical Trials

Find Lung Cancer Clinical Trials Near You

A Randomized Controlled Trial of gEneral aneStheSia vs consciOUs Sedation in Radial endobronChial Ultrasound for Peripheral Pulmonary lEsions

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The endoscopic investigation of lung lesions is experiencing significant growth with the increasing number of lung cancer screening programs. Peripheral endobronchial ultrasound (pEBUS) is the most widely used endoscopic technique in the investigation of peripheral pulmonary lesions (PPL). It is performed in relatively equal proportions under conscious sedation and general anesthesia by interventional pulmonologists throughout the world. Users of conscious sedation justify themselves by the fewer resources consumed and the absence of demonstration of a superior diagnostic yield of general anesthesia while users of general anesthesia claim diagnostic yield and comfort for the patient are superior with their approach. Our main objective is to compare the diagnostic yield of pEBUS under general anesthesia to that obtained under conscious sedation.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years and ability to consent

• Peripheral lung lesion less than 5cm in average diameter on axial CT images (A lung lesion will be considered peripheral if it is located beyond the origin of the subsegmental bronchi and presumed not to be visible endoscopically in white light during the evaluation of the CT scan by an interventional pulmonologist.)

• Lesion deemed accessible by pEBUS by an experienced interventional pulmonologist

• Decision by the medical team and the patient to use pEBUS as a diagnostic modality for the lung lesion

Locations
Other Locations
Canada
Institut universitaire de cardiologie et de pneumologie de Québec
RECRUITING
Québec
Contact Information
Primary
Marc Fortin, MD
marc.fortin@criucpq.ulaval.ca
418-656-8711
Time Frame
Start Date: 2025-09-25
Estimated Completion Date: 2029-08
Participants
Target number of participants: 306
Treatments
Experimental: Conscious sedation arm
In the conscious sedation group, the procedure will be performed through the nose or mouth at the discretion of the endoscopist. The patient will remain breathing spontaneously throughout the procedure and will be administered oxygen through a nasal cannula at an initial flow rate of 2L/min. A combination of propofol, fentanyl and midazolam boluses will be used to maintain moderate sedation. At IUCPQ-UL, fentanyl and midazolam will be used as in our routine practice. The boluses will be prescribed by a doctor experienced in conscious sedation (anesthesiologist, intensivist or pulmonologist) according to the patient's state of wakefulness assessed by the Richmond Agitation-Sedation Scale (RAS) .Centers will decide, prior to initiating recruitment locally, the drug combination used to sedate patients and they will maintain the use of the same drug combination throughout the study.
Experimental: General anesthesia arm
In the general anesthesia group, an endotracheal tube larger than 7 will be used. The patient will be kept non-arousable to non-nociceptive stimulation (RAS = -5) by a perfusion including, at the anesthesiologist's discretion: fentanyl, sufentanyl, remifentanyl, midazolam or propofol. The sedation of this group will not be protocolized given the wide variety of practices in the participating centers, but the targeted level of sedation will be and the medication administered will be adjusted according to this target. The RAS will be evaluated every 5 minutes, or earlier if signs of arousal are present, to ensure that the intended target is maintained and adjustments to the rate of infusions as well as boluses may be made/administered by the anesthesiologist to maintain the targeted level of sedation. Patients may be paralyzed at the discretion of the anesthesiologit. The ventilatory parameters will be standardized according to the VESPA protocol
Related Therapeutic Areas
Sponsors
Leads: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

This content was sourced from clinicaltrials.gov